Validation Lead

Purpose and Scope

• Lead the daily operations of the Validation function, managing Validation Engineers (staff and outsourced providers), coordinating activities, and improving operational efficiency.
• Ensure facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning procedures, analytical methods, and aseptic operations perform as intended and reliably produce safe, effective, and compliant biopharmaceutical products.
• Provide strategic leadership across the validation lifecycle—planning, execution, review, approval, and maintenance—aligned with GMP, data integrity principles, and risk-based methodologies. Own the Site Validation Master Plan (VMP), champion cross-functional governance, and drive continuous improvement to maintain a validated state.

Role and Responsibilities

• Lead and develop the Validation team; foster an engaged, psychologically safe, high-performance culture aligned with Astellas values.
• Ensure stable supply and delivery of departmental objectives; resolve issues, prioritise effectively, and drive continuous improvement via ambitious KPIs.
• Maintain compliance with GMP, GDP, environmental, safety, and governance requirements; ensure audit readiness and robust data integrity.
• Contribute to site and global strategy; deliver strategic projects on time and within budget while anticipating future trends and skill needs.
• Lead implementation of new products, technologies, systems, and procedures; ensure compliant change management and effective knowledge transfer.
• Build strong cross-functional and global partnerships; support business continuity, mitigate risks, and deputise for site leaders as required.

Essential Qualifications

• Bachelor’s degree (or equivalent) in an Engineering or Scientific discipline, or proven relevant in-depth experience.

Preferred Qualifications

• Extensive experience in a similar role with strong technical competence and validation leadership capability (cGMP start-up experience advantageous).
• Proven ability to progress complex technical projects, support commissioning/maintenance of cGMP manufacturing, and manage multiple priorities.
• Excellent organisational, interpersonal, verbal, and written communication skills; able to work independently and collaboratively; open to new ideas.

Benefits

• Why Astellas
• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.